Regulatory Affairs Manager - Emerging Markets

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><h1><b>Regulatory Affairs – Senior Role Summary</b></h1><h2><b>1. Product Registrations &amp; Submissions</b></h2><ul><li>Provide high‑level regulatory leadership for global development programs and commercial products across <b>Emerging Markets</b> (defined as all regions <i>except</i> Switzerland, the United States, Europe, Canada, and Australia).</li><li>Define, drive, and optimize global regulatory strategies, ensuring full alignment with cross‑functional stakeholders.</li><li>Determine data requirements, evaluate scientific evidence against regulatory standards, and ensure robust dossier quality.</li><li>Lead the preparation, review, and approval of complex registration packages and responses to agency inquiries.</li><li>Maintain complete oversight of filings, approvals, and regulatory documentation throughout the product life cycle.</li><li>Develop strategy and briefing materials for Health Authority interactions, ensuring consistent and well‑positioned company messaging.</li></ul><h2><b>2. Cross‑Functional Leadership</b></h2><ul><li>Represent Regulatory Affairs in senior internal forums, articulating clear regulatory positions and influencing decision‑making across Development, Manufacturing, Quality, and Commercial functions.</li><li>Monitor program execution against strategic plans and timelines, identifying risks and enabling proactive mitigation.</li><li>Provide authoritative regulatory insight to support program progression and operational decision‑making.</li></ul><h2><b>3. Life‑Cycle Compliance</b></h2><ul><li>Evaluate and approve manufacturing and technical changes with regulatory impact, ensuring timely updates to global submissions.</li><li>Ensure investigational submissions remain current throughout all phases of development.</li><li>Continuously monitor global regulatory legislation and assess implications for regional business operations and compliance.</li><li>Oversee ongoing regulatory compliance of marketed products across their life cycle.</li></ul><h2><b>4. Regulatory Strategy &amp; Business Partnership</b></h2><ul><li>Advise senior stakeholders—including Commercial, Quality, Manufacturing, Development, and Business Development—on regulatory requirements and strategic risks.</li><li>Define global and regional regulatory pathways for new product registrations and key lifecycle submissions.</li><li>Provide expert regulatory assessment and strategic guidance during in‑licensing evaluations and due diligence.</li></ul><h2><b>5. Continuous Improvement &amp; Operational Excellence</b></h2><ul><li>Identify opportunities to streamline regulatory processes, enhance operational efficiency, and strengthen cross‑functional execution.</li><li>Drive implementation of improved practices that elevate regulatory quality and accelerate timelines.</li></ul><h2><b>6. Health Authority Engagement</b></h2><ul><li>Participate in Health Authority meetings, representing company regulatory strategy with clarity, confidence, and scientific rigor.</li></ul><h2><b>7. Licensing Responsibilities</b></h2><ul><li>Serve as the primary RA representative for in‑licensing opportunities, independently evaluating regulatory risks, feasibility, and integration pathways.</li></ul><h1><b>Core Responsibilities</b></h1><ul><li>Provide strategic regulatory direction for assigned projects, including complex or novel issues.</li><li>Lead cross‑functional inputs to create strong regional regulatory plans.</li><li>Prepare and oversee high‑quality submissions, ensuring scientific consistency and alignment with company positions.</li><li>Track and report program status, escalating issues and recommending solutions where needed.</li><li>Deliver clear, persuasive written and verbal communication to internal teams and leadership.</li><li>Maintain expert knowledge of evolving regulatory guidelines and translate regulatory intelligence into actionable strategy.</li><li>Ensure accuracy, compliance, and scientific integrity of all regulatory deliverables.</li></ul><h1><b>Position Scope &amp; Impact</b></h1><ul><li>Operates autonomously with minimal supervision, managing significant regulatory responsibilities across multiple functions and geographies.</li><li>Partners closely with EPD RA, Affiliate RA teams, and regional stakeholders in Commercial, QA, Operations, and Development.</li><li>Accountable for timely and high‑quality completion of all assigned regulatory activities.</li><li>No direct budget responsibility; however, expected to identify cost‑saving opportunities and ensure efficient resource use.</li><li>Anticipates regulatory risks, proactively resolves issues, and incorporates learnings to strengthen future regulatory strategies.</li><li>Ensures consistent interpretation and application of regulatory policies across project teams.</li></ul><h1><b>Minimum Qualifications</b></h1><ul><li>Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or related scientific discipline.</li><li>Advanced degree (Master’s or equivalent) strongly preferred.</li></ul><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Regulatory Operations<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>EPD Established Pharma<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>Netherlands &gt; Weesp : WHS 02<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>Not specified<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>